(78 days)
PVA particles are indicated for vascular occlusion of blood vessels within the neurovascular and peripheral vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.
The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single use.
The provided text is a 510(k) summary for medical devices, specifically PVA Foam Embolization Particles. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies or establishing detailed acceptance criteria through novel testing.
Therefore, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically part of a new device approval process (like a PMA), not a 510(k) for substantial equivalence.
The key takeaway from the document is:
- There are no new performance acceptance criteria or studies described. The basis for clearance is substantial equivalence to existing predicate devices.
- The device is identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. (K001678, K053548, K061790). The only changes are the manufacturer and distributor identification.
Given this, I cannot fill in the requested table and details about acceptance criteria and studies because they are not present in the provided text.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).